EN PL

FDA: Guidance for Industry Clinical Trial Endpoints for the Approval of Non-Small Cell Lung Cancer Drugs and Biologics

16.06.2011
The purpose of this guidance is to provide recommendations to applicants on endpoints for non¬21 small cell lung cancer (NSCLC) clinical trials submitted to the Food and Drug Administration 22 (FDA) to support effectiveness claims in new drug applications (NDAs), biologics license 23 applications (BLAs), or supplemental applications. This guidance is a companion to the 24 guidance for industry Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics.